Phase II NCCTG trial of oral topotecan and paclitaxel with G-CSF (filgrastim) support in patients with previously untreated extensive-stage small cell lung cancer

Julian R. Molina, James R. Jett, Nathan Foster, Bradley S. Lair, Thomas J. Carroll, Henry D. Tazelaar, Shauna Hillman, James A. Mailliard, Albert M. Bernath, Daniel Nikcevich

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

OBJECTIVE: To determine the efficacy and toxicity of oral topotecan and paclitaxel in untreated patients with extensive stage small cell lung cancer (SCLC). PATIENTS AND METHODS: Thirty-eight patients received 1.75 mg/m of oral topotecan days 1 to 5 and 175 mg/m paclitaxel IV over 3 hours on day 5 (after topotecan) every 4 weeks for 6 cycles. Subcutaneous G-CSF at a dose of 5 μg/kg was then given 24 to 48 hours after the last dose of chemotherapy and daily for 10 days. RESULTS: All 38 patients were available for toxicity and response analysis. A median of 5 treatment cycles was given, with a range of 1 to 7 cycles. Seventeen (45%) patients received at least 6 cycles of treatment. The most common severe adverse events were neutropenia (42.1%), leukopenia (34.2%), thrombocytopenia (18.4%), nausea (18.4%), diarrhea (13.2%), and fatigue (13.2%). Two grade 5 treatment-related evens were seen. The median overall survival was 9.1 month (95% CI: 7.5-13.0 months), with a 1-year survival estimate of 44.7% (95% CI: 31.4-63.7%) and a 2-year survival rate of 5.3% (95% CI: 1.4-20.3%). The median time to progression was 5.0 months (95% CI: 3.8-6.6 months), with a 1-year progression-free rate of 5.8% (95% CI: 1.5-22.2%) and a 2-year progression-free rate of 2.9% (95% CI: 0.4-19.9%). The estimated confirmed response rate was 52.9%. CONCLUSION: This regimen has shown similar antitumor activity to that achieved with standard therapy. Because of unacceptable toxicity and cost, we do not recommend this regimen in a palliative setting.

Original languageEnglish (US)
Pages (from-to)246-251
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume29
Issue number3
DOIs
StatePublished - Jun 2006

Keywords

  • Oral topotecan
  • Paclitaxel
  • SCLC

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